Efficacy of Oral liposomal iron, Oral Ferrous sulphate, and Intravenous iron sucrose in antenatal women between 16-28 weeks of gestation with moderate anaemia - A Randomized controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Increase in Hemoglobin levels after taking the prescribed or administered drug to the patient over a period of 4 weeks in which we will study the Efficacy of Oral liposomal iron when compared to Oral ferrous sulphate and Intravenous iron sucrose in treatment of moderate anemia in pregnancy.
研究概览
简要总结
After getting IEC clearance from the institute and CTRI registration, informed and written consent from the patient who are willing to get enrolled in the study. Antenatal patients between 16-28 weeks of gestation attending OBG OPD will be undergone biochemical testing [Complete Hemoglobin count (CBC), Serum Ferritin, Hematocrit, Peripheral smear study] to identify the Iron deficiency anemia. Patients who are diagnosed with moderate anemia after meeting the inclusion criteria are included in the study. Patient is randomized and started allocating them in the respective study groups. One group will be started with oral liposomal iron 30mg twice daily; another group will be started with oral ferrous sulphate 60mg twice daily and the last group will be administered with 200mg Iron sucrose intravenously once weekly (Based on iron requirement). Patients will be followed up for 4 weeks for side effects. Oral compliance for both oral drugs will be collected through questionnaire. Hemoglobin levels are repeated after 4 weeks and data are collected for analysis of outcome.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 19.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- Female
入选标准
- •Antenatal women between 16 to 28 weeks of gestation.
- •Antenatal women with Hemoglobin level between 7 – 9.9g% (Moderate anemia according to WHO) 3) Women with established iron deficiency anemia 4) Women with no prior history of blood transfusion.
排除标准
- •Antenatal women belong to First trimester (1-12 weeks of gestation) and more than 32 weeks of gestation 2) Women with medical complications/ Hematological disorders 3) Women with Hemoglobinopathies 4) Liver disorder like jaundice, cirrhosis, or renal failure 5) Antenatal women with Hemoglobin level less than 7g%.
结局指标
主要结局
Increase in Hemoglobin levels after taking the prescribed or administered drug to the patient over a period of 4 weeks in which we will study the Efficacy of Oral liposomal iron when compared to Oral ferrous sulphate and Intravenous iron sucrose in treatment of moderate anemia in pregnancy.
时间窗: 4 weeks
次要结局
- 1) To study the patient’s compliance of oral liposomal iron in treatment of anemia in pregnancy.(2) To observe the compliance of oral ferrous sulphate in treatment of anemia in pregnancy.)
研究者
Shobika B
Aarupadai Veedu Medical College and Hospital